Takipril 20 mg/ml Prilocaine Hydrochloride Solution for Injection
What Takipril Is And What Takipril Used For
Takipril 20 mg/ml is a type of medicine called a local anaesthetic, belonging to the amide group and is a solution for injection. Takipril is used in adults to numb specific body parts and prevent pain during surgery.
Takipril is injected into the lower part of the spine. This quickly stops pain from the waist down for a limited time (short-term surgical procedures).
Prilocaine hydrochloride contained in Takipril may also be approved to treat other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have further questions, and always follow their instructions.
What You Need To Know Before You Receive Takipril
Takipril Must Not Be Given To You
- If you are allergic to prilocaine hydrochloride, other amide-type local anaesthetics, or any of the other ingredients of this medicine (listed in section 6),
- If you have serious conduction problems in the heart,
- If you suffer from severe anaemia,
- If you have untreated heart failure,
- If you are in shock because the heart’s pumping ability fails and the amount of blood in the body is too little,
- If you suffer from congenital or acquired methemoglobinemia,
- If there are general or specific conditions or factors that make the technique used in spinal anaesthesia inappropriate.
Takipril must not be injected into a blood vessel. Takipril must not be used in children younger than 6 months.
Warnings And Precautions
Talk to your doctor before receiving Takipril:
- If you have had a severe reaction to an anaesthetic in the past
- If you have a skin infection at or near the proposed injection site
- If you suffer from any of the following:
- Diseases of the central nervous system such as meningitis, polio, and problems with your spinal cord due to lack of blood
- Severe headache
- Tumours in the brain, spine, or other tumours
- Tuberculosis of the spine
- Recently had an injury to the spine
- Very low blood pressure or low blood volume in the body
- Problems with the blood’s ability to clot
- Acute porphyria
- Fluid in the lungs
- Blood poisoning
- If you have problems with the heart e.g.
- Total or partial heart block
- Heart failure
- Rhythm disturbances
- If you have liver or kidney problems
- If you suffer from a neurological disease, such as
- Multiple sclerosis
- Unilateral paralysis
- Bilateral paralysis
- Neuromuscular diseases
- If you have a reduced general condition.
Doctors with sufficient knowledge and experience may only give takipril spinal anaesthesia. The attending physician is responsible for taking the necessary measures to avoid injection into a blood vessel and to be able to recognize and treat side effects.
Children And Young People
Takipril is not recommended for children and adolescents. Takipril’s safety and efficacy in children and adolescents have not been established. No data is available.
Takipril must not be given to children younger than 6 months due to the increased risk of developing methemoglobinemia.
Other Medicines And Takipril
Tell your doctor if you have recently taken or might be taking any other medicines, even those without a prescription. This is especially true if you take medicines for irregular heart rhythm (class III antiarrhythmics ) and pain.
Pregnancy And Breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor before receiving this medicine. Your doctor will decide if you can receive an injection of Takipril. Prilocaine should not be given for local or regional anaesthesia during labour.
It is not known whether prilocaine passes into breast milk. Breastfeeding can be resumed approximately 24 hours after treatment.
Driving Ability And Use Of Machinery
Do not drive or work with tools or machines, as Takipril may temporarily affect your ability to react and muscle coordination.
You are responsible for assessing whether you can drive a motor vehicle or perform work requiring increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and side effects.
A description of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. Discuss with a doctor or pharmacist if you are unsure.
Taquipril Contains Sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose (maximum dose of 4 ml Takipril solution for injection ), i.e. it is almost “sodium-free”.
How Takipril Is Used
- Your doctor will give you this medicine and decide which dose is correct.
- The usual dose for adults is 40-60 mg prilocaine hydrochloride (2-3 ml Takipril). The maximum dose is 80 mg prilocaine hydrochloride (4 ml Takipril).
- The doctor will give you Takipril in the lower part of your spine while sitting or lying down.
- Takipril is not recommended for children and adolescents. Takipril’s safety and efficacy in children and adolescents have not been established.
- Takipril must not be given to children younger than 6 months due to the increased risk of developing methemoglobinemia.
- In patients with poor general conditions and with diagnosed concomitant diseases (e.g. blockage of blood vessels, arteriosclerosis, disease of peripheral nerves caused by diabetes (diabetic polyneuropathy ), a dose reduction is necessary.
- A lower dose level is recommended in case of reduced liver or kidney function.
- Takipril is injected into the spinal fluid.
- Equipment, drugs and personnel capable of dealing with an emergency must be in the immediate vicinity. Rare cases of serious reactions have been reported following local anaesthetics, even in patients who have not previously suffered from hypersensitivity.
If You Have Received Too Much Takipril
The doctor who gives you Takipril is experienced in giving local anaesthetic to the spinal cord, so it is unlikely that you will get overdose. If a dose is accidentally injected directly into the bloodstream, you may experience
- Short-term vision or hearing problems
- Muscle twitching
- Tremors
- Convulsions (seizures)
- Loss of consciousness
When you receive Takipril, equipment will be available to treat you if an overdose occurs. If you have any further questions about this medicine, ask your doctor or pharmacist.
Possible Takipril Side Effects
This medicine can cause side effects like all medicines, although not everybody gets them.
As with all local anaesthetics, arterial pressure may drop, and heart rate may slow. You may feel nauseous, have low blood pressure or have a slower heartbeat. Other possible side effects are headaches after surgery, vomiting and difficulty urinating.
Possible side effects are:
Very common: may affect more than 1 in 10 users
- Lowered blood pressure
- Nausea
Common: may affect up to 1 in 10 users
- Numbness
- Dizziness
- Vomiting
Uncommon: may affect up to 1 in 100 users
- Cramps
- Numbness around the mouth
- Unconsciousness
- Tremors
- Tongue numbness
- Speech difficulties
- Hearing problems
- Tinnitus
- Visual disturbances
- Back pain
- Temporary muscle weakness
- Slow heartbeat
- Increased blood pressure
Rare: may affect up to 1 in 1,000 users
- Methemoglobinemia (a disorder in the blood’s ability to absorb oxygen and release carbon dioxide)
- Reduced blood oxygenation with bluish skin and lips (cyanosis)
- Anaphylactic shock
- Anaphylactic reactions
- Allergic reactions
- Itching
- Inflammation of the membranes surrounding the spine (arachnoiditis)
- Numbness or weakness in the arms and legs ( neuropathy )
- Damage to peripheral nerves
- Double vision
- Cardiac arrest
- Irregular heartbeat
- Impaired respiratory function
Takipril is unlikely to cause serious side effects unless it is accidentally given in the wrong way or used with other local anaesthetics. If this happens,
- Numb tongue
- Clouding
- Dizziness
- Tremors
Convulsions may occur. In extremely rare cases, prilocaine has been associated with
- Heart attack
- Difficulty breathing
- Loss of sensation in the lower part of the body and allergic reactions may cause skin rash, swelling or very low blood pressure.
- A rare but serious side effect of takipril spinal anaesthesia is a high or complete spinal cord blockade, which leads to severely reduced cardiovascular and lung function.
How To Store Takipril
- Keep this medicine out of sight and reach of children.
- Use before the expiry date stated on the ampoules and carton after EXP. The expiration date is the last day of the specified month.
- Store at a maximum of 25 ºC. Store protected from cold. Do not freeze.
- Store in the original packaging. Light sensitive.
- Use immediately after opening.
- This medicine must not be used if the solution is not clear and free of particles.
- Leftover medicine should be thrown away. As the medicine is only given in the hospital, the hospital takes care of the destruction. These measures will help to protect the environment.
Contents Of The Packaging And Other Information
Contents Declaration
- The active substance is prilocaine hydrochloride.
- 1 ml solution for injection contains 20 mg prilocaine hydrochloride (equivalent to 2%).
- 1 ampoule with 5 ml of solution contains 100 mg of prilocaine hydrochloride.
- Other ingredients are:
- Anhydrous glucose or glucose monohydrate
- Sodium hydroxide 1N (for pH adjustment)
- Water for injections
Appearance And Package Sizes Of The Medicine
- Solution for injection. Clear colourless solution.
- This solution is supplied in clear, colourless glass ampoules, type I.
- Carton of 10 ampoules, each containing 5 ml solution for injection.
Marketing Authorization Holder And Manufacturer
Marketing Authorisation Holder
B. Braun Melsungen AG
Carl-Braun-Strasse 1
34212 Melsungen
Germany
Mailing address:
34209 Melsungen, Germany
Manufacturer
Sirton Pharmaceuticals SpA
Piazza XX Settembre 2
22079 Villa Guardia (CO)
Italy
Sintetica GmbH
Albersloher Weg 11
48155 – Münster
Germany
Agent : B. Braun Medical AB, Box 110,
182 12 Danderyd